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Completed

NCT Number: NCT05994768

18F-FDG Tomography and Labeled Leukocyte Scintigraphy

The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Verger Antoine

Vandœuvre-lès-Nancy, 54511, France

About this study

The management of malignant otitis externa (MEO) is a major issue in patients who are often polypathological and fragile. Appropriate antibiotic therapy must be started quickly after the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major role in assessing the extent of the infection and especially healing, after 6 weeks of antibiotic therapy. The persistence of an infection at the end of the treatment, observed in imaging, will allow a change of antibiotic line. This study consists in studying in a population affected by an OEM, the performance of PET/CT with 18F-FDG compared to scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the pathology after antibiotic therapy has already been proven in the literature. The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy

Exclusion criteria

  • patients who refuse to have their imaging data used

Treatment and study plan

18F-FDG PET/CT

Other

Patients who underwent an 18F-FDG PET/CT examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an EO.

Other names: scintigraphy with labeled leukocytes

Primary outcomes

  1. 18F-FDG positron emission tomography

    Time frame: one day

    measurement of standard uptake value

  2. Labeled leukocyte scintigraphy

    Time frame: one day

    measurement of standard uptake value

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Comparison of the Performance of 18F-FDG PET/CT With That of Labeled Leukocyte Scintigraphy in the Follow-up of Malignant Otitis Externa.

Acronym: OEN

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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